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Shining Light on Pancreatic Cancer
Supported by educational grants from Celgene Corporation and Aduro Biotech
Provided by MediCom Worldwide, Inc. Faculty
Nina N. Grenon, DNP, AGCNP‐BC, AOCN
Nurse Practitioner
Center for Gastrointestinal Oncology
Dana Farber Cancer Institute
Boston, Massachusetts Carmela L. Hoefling, MSN, APN, AOCNP
Advanced Practice Nurse
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey Vincent Picozzi, Jr., MD, MMM Director
Pancreas Center of Excellence Virginia Mason Medical Center Seattle, Washington
Agenda
Dinner will be available during the program.
*All times are listed in Central Daylight Time*
6:15 PM – 6:20 PM
Welcome and Introductions
6:20 PM – 6:30 PM
FAST FACTS: Myths and Facts in Pancreatic Cancer
Carmela L. Hoefling, MSN, APN, AOCNP
6:30 PM – 7:00 PM
The Current Landscape in the Treatment of Advanced Metastatic
Pancreatic Cancer: Helping You Help Your Patients
Vincent J. Picozzi Jr, MD
7:00 PM – 7:20 PM
Taking Steps to Assure a Patient‐centered Approach to Treatment:
Shining Light of Palliative Care
Nina N. Grenon, DNP, AGCNP‐BC, AOCN
7:20 PM – 7:30 PM
Care Challenges in Pancreatic Cancer
Panel Discussion led by Carmela L. Hoefling, MSN, APN, AOCNP Audience Q&A
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Shining Light on Pancreatic Cancer
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Fast Facts: Myths and Facts in Pancreatic Cancer
Carmela L. Hoefling, MSN, APN, AOCNP
Advanced Practice Nurse
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey
The Pancreas
Liver
Stomach
Gallbladder
Common bile duct
Pancreas
Duodenum (small intestine)
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Shining Light on Pancreatic Cancer
The Pancreas Has Two Functions
Exocrine
The pancreas produces enzymes that help to digest food
Amylase
Lipase
Protease
2 Functions
Endocrine
The pancreas produces chemicals (hormones) that regulate blood sugar
Glucagon
Insulin
Somato‐
statin
Pancreatic polypeptide
Pancreatic Cancer 2015
Average Lifetime Risk of Pancreatic Cancer: US: 48,960
Worldwide
3% of All New Cancer Cases in the US
1 in 65
Cases Reported Worldwide:
280,000 New Cases Annually
New Cancers Reported in the US
http://seer.cancer.gov/statfacts/html/pancreas.html
Stages of Disease
 Stage 0
The tumor is confined to the top layers of pancreatic duct cells and
has not invaded deeper tissues. It has not spread outside of the pancreas
 Stage IA
The tumor is confined to the pancreas and is 2 cm across or smaller.
The cancer has not spread to nearby lymph nodes or distant sites
 Stage IB
The tumor is confined to the pancreas and is larger than 2 cm across. The cancer has not spread to nearby lymph nodes or distant sites
 Stage IIA
The tumor is growing outside the pancreas but not into major blood vessels or nerves. The cancer has not spread to nearby
lymph nodes or distant sites
 Stage IIB
The tumor is either confined to the pancreas or growing outside the pancreas but not major blood vessels or nerves. The cancer has spread to nearby lymph nodes but not to distant sites
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
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Shining Light on Pancreatic Cancer
Stages of Disease
 Stage III
The tumor is growing outside the pancreas and into nearby major blood vessels or nerves. The cancer may or may not have spread to nearby lymph nodes. It has not spread to distant sites
 Stage IV
The cancer has spread to distant sites
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
Metastatic Pancreatic Cancer
Systemic Chemotherapy
Local Pancreatic Cancer
Locally Advanced
Chemoradiation Therapy
Borderline Resectable
Resectable
Surgical Resection
Adjuvant Chemotherapy
How Much Do You Know About Pancreatic Cancer?
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Shining Light on Pancreatic Cancer
Myth or Fact?
Surgical resection is the only potentially curative treatment for exocrine pancreatic cancer
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
Fact
**Surgical resection only potentially curative treatment**
• Etiology of pancreatic cancer is poorly understood
• More than half diagnosed at advanced stage
• Difficult to detect and diagnose:
- Early stages with no noticeable signs or symptoms
- Symptoms like many other illnesses
- Obscured by other organs
- Can be difficult to see on imaging
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
Myth or Fact?
Obesity is the #1 most modifiable risk factor for pancreatic cancer.
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
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Shining Light on Pancreatic Cancer
Non‐inherited Risk Factors
Diabetes Mellitus
Diet
Age
Race/Ethnicity
Smoking #1 Modifiable Risk Factor
Chronic Pancreatitis
Gender
Obesity/Physical Inactivity
Cystic Lesions of the Pancreas
Decker GA, et al. Gastroenterol Hepatol (NY). 2010;6 (4)246‐254.
Inherited Risk Factors
• Familial pancreatic cancer
• Cystic fibrosis
• Genetic syndromes
- Hereditary pancreatitis
- Breast/ovarian cancer syndrome: BRCA 2
- Hereditary nonpolyposis: Mismatch repair genes
- Familial atypical multiple mole melanoma (FAMM)

CDKN2A mutation
Decker GA, et al. Gastroenterol Hepatol (NY). 2010;6 (4)246‐254.
Myth or Fact?
New onset diabetes is the most common presentation of pancreatic cancer
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
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Shining Light on Pancreatic Cancer
Signs and Symptoms
Depressed mood
Fatigue
New‐onset diabetes mellitus
#1 sign: Painless, obstructive jaundice
Nonspecific GI symptoms
Mild, progressive mid‐abdominal pain; can radiate to back
Anorexia/ weight loss
Zhang Q, et al. Gastroenterol Res Pract. 2016;2016:8962321.
Work Up
• Labs: CMP, CBC, CA19‐9, prealbumin, LFTs, lipase
• Imaging
- Abdominal US
- Abdominal CT scan pancreatic protocol
- CT scan chest
- MRI/MRCP
- PET scan
• EGD/EUS with biopsy
- Tissue diagnosis
- Staging
• ERCP
• Diagnostic laparoscopy
Myth or Fact?
Pain is the #1 most feared symptom among cancer patients
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
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Shining Light on Pancreatic Cancer
Management of Locally Advanced Symptoms R/T Disease Progression
1.
Pain related to infiltration of retroperitoneal nerves
**Most feared symptom**
2.
Biliary obstruction
3.
Gastric outlet obstruction (GOO)



4.
Opiates, celiac plexus block, radiation
Jaundice, pruritus, malabsorption, coagulation issues, pain
Intractable N/V, anorexia, weight loss, malnutrition, dehydration, electrolyte abnormalities
Pancreatic exocrine insufficiency

Diarrhea, bloating, indigestion, steatorrhea, malabsorption
www.uptodate.com/contents/pancreatic‐cancer. February 2016.
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
Management of Locally Advanced Symptoms R/T Disease Progression
5.
Venous thromboembolism
6.
Fatigue


7.
DVT, PA, DIC, PV thrombosis, arterial thromboembolism
Depression, pain, opioids, anemia, chemotherapy, insomnia, dehydration, cachexia
Depression

Impacted by pain
www.uptodate.com/contents/pancreatic‐cancer. February 2016.
National Cancer Institute: PDQ® Pancreatic Cancer Treatment. Bethesda, MD. Last modified 01/14/2016. Available at www.cancer.gov/types/pancreatic/patient/pancreatic‐treatment‐pdq. Accessed 04/19/2016.
Why Do All Nurses NEED to Know About Pancreatic Cancer?
 Pancreatic cancer knows no bounds...it can strike anybody, at anytime  It is the only leading cancer killer with a 5‐year survival rate still in the single digits
 It is referred to as a silent killer – it’s difficult to detect and spreads so quickly
 Vague symptoms including back/abdominal pain, jaundice and nausea usually appear after the cancer is at an advanced stage making it difficult to treat
 Few patients diagnosed with pancreatic cancer have identifiable risk factors
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Shining Light on Pancreatic Cancer
SHARE YOUR KNOWLEDGE
Vincent Picozzi, Jr., MD, MMM Director
Pancreas Center of Excellence Virginia Mason Medical Center Seattle, Washington
Pancreas Cancer is the Most Challenging Cancer to Treat
Year of diagnosis
Median survival (months)
5‐year survival
1974
2.8
2.0%
1979
3.2
2.2%
1984
3.3
2.2%
1989
3.5
2.8%
1994
3.6
4.0%
1999
4.0
4.6%
2004
4.3
5.0%
2004‐2011
4.8
6.2%
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Shining Light on Pancreatic Cancer
Pancreas Cancer is the Most Challenging Cancer to Treat
Median survival (months)1
5‐year survival3
Resected
20.9
Stage I
22.6%
Locally Advanced2
7.6
II
11.4%
Metastatic
2.9
III
3.0%
Overall4
3.8
IV
1.7%
Overall4
6.0
1www.seer.cancer.gov/seerstat. Surveillance Research Program, NCI SEER*Stat software. Version 8.3.0. 2Katz MH, et al. CA Cancer J Clin. 2008;58:111‐125. 3National Cancer Database 2003‐2007. 4Excludes patients with unknown stage.
Pancreas Cancer is the Most Challenging Cancer to Treat: Biologic Challenges
 Genetically complex
 Stromal symbiosis
 Immunologically quiescent
 Early metastasis
 Large systemic impact (eg, pain, depression, weight loss)
Clinical Challenges in Increasing Pancreatic Cancer Survival
 Most patients diagnosed with advanced disease, currently no reliable markers for early detection
 Ineffective systemic therapies
 Majority of patients treated outside of multi‐
disciplinary setting  Older average age at diagnosis → comorbidity and low treatment tolerance
 Pervasive nihilism among medical professionals
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Shining Light on Pancreatic Cancer
Pancreas Cancer Pyramid of Success
Early Detection
Better Drugs
Multidisciplinary Teams
Supportive Care
Optimism
Hope
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Shining Light on Pancreatic Cancer
Pancreas Cancer: Seven Important Complications
1. Pain
2. Depression
3. Diabetes
4. Weight loss
5. Nausea/vomiting, gastric blockage
6. Biliary obstruction/infection
7. Clotting and bleeding
Nutritional Intervention Can Improve QOL and Overall Survival in Advanced Pancreatic Cancer
• Dietary counseling and oral •
•
•
•
nutrition supplements over weeks n=107
Improved dietary intake
Weight stabilization
Improved QOL (EORTC)
Improved OS
8 Davidson W, et al. Clin Nutr. 2004;23(2):239‐247.
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Shining Light on Pancreatic Cancer
Pancreas Cancer: Basic Presentations
Pancreas Cancer
Localized
Metastatic
Metastatic Pancreas Cancer: The Future of Treatment
Patient Preference
Tumor biology
1st Line
Comorbidity
Economics
2nd Line
3rd Line
Gemcitabine Monotherapy in 1st‐
Line Metastatic Pancreatic Cancer
Median OS
Gemcitabine 5.7 mo
5‐FU 4.4 mo
Burris HA 3rd, et al. J Clin Oncol. 1997;15(6):2403‐2413.
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Shining Light on Pancreatic Cancer
What is Better than Gemcitabine??
FOLFIRINOX in 1st‐Line Metastatic Pancreatic Cancer
FOLFIRINOX
1.00
Probability
Gemcitabine
0.75
Median 11.1 mo
HR = 0.57
P < .0001
0.50
0.25
Median 6.8 mo
0.00
0 3 6 9 12 15 18 21 24 27 30 33 36
Months
Conroy T, et al. N Engl J Med. 2011;364:1817‐1825.
FOLFIRINOX: Major Toxicities
Most Common Grade 3 or 4 Adverse Events Occurring in More than 5% of Patients in the Safety Population*
Event
FOLFIRINOX (N = 171)
Gemcitabine (N = 171)
P Value
no. of patients/total no. (%)
Hematologic
Neutropenia
35/167 (21.0)
<0.001
Febrile neutropenia
9/166 (5.4)
2/169 (1.2)
0.03
Thrombocytopenia
75/164 (45.7)
15/165 (9.1)
6/168 (3.6)
0.04
Anemia
13/166 (7.8)
10/168 (6.0)
NS
Fatigue
39/165 (23.6)
30/169 (17.8)
NS
Vomiting
24/166 (14.5)
14/169 (8.3)
NS
Diarrhea
21/165 (12.7)
3/169 (1.8)
<0.001
Nonhematologic
Sensory neuropathy
15/166 (9.0)
0/169
<0.001
Elevated level of alanine aminotransferase
12/165 (7.3)
35/168 (20.8)
<0.001
Thromboembolism
11/166 (6.6)
7/169 (4.1)
NS
*Events listed are those that occurred in more than 5% of patients in either group. NS=not significant.
Conroy T, et al. New Engl J Med. 2011;364:1817‐1825.
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Shining Light on Pancreatic Cancer
Gemcitabine/Nab‐paclitaxel in 1st‐
Line Metastatic Pancreatic Cancer
OS, Months
Median (95% Cl)
Gem + Nab‐P: 8.5 (7.89 – 9.53)
Gem: 6.7 (6.01 – 7.23)
HR = 0.72
95% CI (0.617‐0.835)
P = .000015
Von Hoff D, et al. N Engl J Med. 2013;369:1691‐1703.
Gemcitabine/Nab‐paclitaxel: Major Toxicities
Common Adverse Events of Grade 3 or Higher and Growth‐Factor Use*
Nab‐Paclitaxel + Gemcitabine (N = 421)
Gemcitabine Alone (N = 402)
18 (4)
18 (4)
Neutropenia
153/405 (38)
103/388 (27)
Leukopenia
124/405 (31)
63/388 (16)
Thrombocytopenia
52/405 (13)
36/388 (9)
Anemia
53/405 (13)
48/388 (12)
110/431 (26)
63/431 (15)
14 (3)
6 (1)
Event
Adverse event leading to death – no. (%)
Grade ≥3 hematologic adverse event – no./total no. (%) †
Receipt of growth factors – no./total no. (%)
Febrile neutropenia – no. (%) ‡
*NA=not applicable, and NR not reached; †Assessment of the event was made on the basis of laboratory values;
‡Assessment of the event was made of the basis of inves gator assessment of treatment‐related adverse events.
Von Hoff D, et al. N Engl J Med. 2013;369:1691‐1703.
Gemcitabine/Nab‐paclitaxel: Major Toxicities
Common Adverse Events of Grade 3 or Higher and Growth‐Factor Use*
Nab‐Paclitaxel + Gemcitabine (N = 421)
Gemcitabine Alone
(N = 402)
Grade ≥3 nonhematologic adverse event occurring in >5% of patients – no. (%) ‡
Fatigue
70 (17)
Peripheral neuropathy §
70 (17)
27 (7)
3 (1)
Diarrhea
24 (6)
3 (1)
113
Grade ≥3 peripheral neuropathy
Median time to onset – days 140
Median time to improvement by one grade – days 21
Median time to improvement to grade ≤1 – days 29
NR
Use of nap‐paclitaxel resumed – no./total no. (%)
31/70 (44)
NA
29
*NA=not applicable, and NR not reached; ‡Assessment of the event was made of the basis of inves gator assessment of treatment‐related adverse events; §Peripheral neuropathy was reported on the basis of groupings of preferred terms defined by standardized queries in the Medical Dictionary for Regulatory Affairs.
Von Hoff D, et al. N Engl J Med. 2013;369:1691‐1703.
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Shining Light on Pancreatic Cancer
5‐FU/MM‐398 as Second‐line Treatment in Metastatic Pancreatic Cancer
Overall Survival: Intent to Treat Population (ITT)*
*Protocol‐defined primary analysis data cut (Feb. 14, 2014, after 305 events). Survival follow‐up is ongoing and the final results will be reported once all patients are off treatment and at least 90% events have taken place. Primary analysis for the study was by un‐stratified log‐rank test; **Un‐stratified HR: 0.67 (0.49‐0.92), P = .0122; ***Un‐stratified HR: 0.99 (0.77‐1.28), P= .9416
Wang‐Gillam A, et al. ESMO 2014.
Pancreas Cancer: Commonly Used Drugs: 2016 • 5‐FU
• Cisplatin
• Gemcitabine
• Oxaliplatin
• Erlotinib
• Irinotecan
• Capecitabine
• Docetaxel
• Nab‐paclitaxel
• MM‐398
Metastatic Pancreatic Cancer: Factors to Consider in Choice of Therapy
Patient
Age
Performance status
Comorbidity
Travel distance
Disease
Metastatic sites
Rate of progression
? Stents (biliary, duodenal)
? Molecular profiling
Therapy
Insurance coverage
IV access required
Drug toxicities
Clinical trial availability
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Shining Light on Pancreatic Cancer
Metastatic Pancreatic Cancer:
Important Current Research Directions
• Novel chemotherapy
• Molecular profiling
• Anti‐stromal therapy
• Immunotherapy
TH‐302: Mechanism of Action
Evofosfamide targets cells in hypoxic zones within the tumor
Many conventional chemotherapeutics address only the cells near the blood vessels
Normoxic Tumor Cell
Hypoxic Tumor Cell
Capillary
Hypoxia Normoxia
(normal oxygen levels)
5% O2
0.5% O2
(low oxygen levels)
dead
alive
Pancreas Cancer: Molecular Navigation
Picozzi V, et al. GI Oncology Symposium 2016.
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Shining Light on Pancreatic Cancer
PEGPH20: Biological Effects
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Shining Light on Pancreatic Cancer
HALO‐301 Phase III Design
Stage IV
Metastatic
PDA
High‐HA
Patients
N = 420
•
•
•
•
PEGPH20 + Paclitaxel protein‐bound + gemcitabine (PAG)
Paclitaxel protein‐
bound + gemcitabine (AG) + placebo
Primary Endpoints:
• Progression‐free survival (PFS)
• Overall survival (OS)
Randomized (2:1 PAG:AG), double‐blind, placebo‐controlled, global
Plan to initiate March 2016, approximately 200 sites in 20 countries
Interim analysis when target number of PFS events reached
PFS powered with a hazard ratio of 0.59 (to detect a 41% risk reduction for progression)
FG‐3019 Suppresses Survival Mechanisms of PDAC Tumor Cells, Sensitizing them to Chemotherapy
 E‐cadherin (green) and cleaved caspase 3 (orange) showed that most apoptotic cells were epithelial
 Apoptosis in presence of FG‐
3019 suggests that CTGF promotes survival of pancreatic tumor cells and resistance to chemotherapeutic agents
 FG‐3019 sensitizes tumor cells to apoptosis by down‐regulation of XIAP expression
Neesse A, et al. Proc Natl Acad Sci USA. 2013;110(30):12325‐12330.
Combined Effects of Baseline CTGF and FG‐3019 Exposure on OS
Baseline CTGF
Day 15 Cmin
Median OS (mo)
1 < median
≥ 150
11.22
2
≥ median
≥ 150
8.62
3
< median
< 150
8.01
4
≥ median
< 150
4.38
Survival Probability
Group
P=.02
OS (months)
Picozzi V, et al. submitted for publication.
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Shining Light on Pancreatic Cancer
Key Attributes of Listeria Monocytogenes for Being an Effective Vaccine Vector
• Two key attributes for inducing robust innate and adaptive immunity
- Naturally targets dendritic cells
- Intracellular localization
• Permit re‐administration to boost existing immune responses
• Practical considerations
- Ease and cost of manufacturing
- Thermostable formulation
• Acceptable safety profile
- Live‐attenuated Listeria actA/inlB
- KBMA Listeria
Kaplan‐Meier Estimates of OS According to Treatment Group Le DT, et al. J Clin Oncol. 2015;33(12):1325‐1333.
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Shining Light on Pancreatic Cancer
Potential Mechanisms of Action of Agonistic CD40 mAb on Various Immune Effectors
Vonderheide RH, et al. Clin Cancer Res. 2013;19:1035‐1043.
Agonist CD40: A Way to Combine Chemotherapy with Immunotherapy?
Beatty GL, et al. Science. 2011;331:1612‐1616.
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Shining Light on Pancreatic Cancer
5‐Year Stage‐specific Survival in Pancreatic Cancer Patients
(diagnosis 2004 – 2011) 45
42.3
↑92% 40
35
30
25
22.4
20
↑68% ↑84% 14.8
15
↑105% 8.8
10
4.1
5
11.4
6.2
2.1
0
Local
*Adjusted to SEER stage distribution
Regional
Distant
VM
Overall*
SEER
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Shining Light on Pancreatic Cancer
Taking Steps to Assure a Patient‐
Centered Approach to Treatment: Shining Light on Palliative Care
Nina N. Grenon, DNP, AGCNP‐BC, AOCN Nurse Practitioner
Center for Gastrointestinal Oncology Dana Farber Cancer Institute
Boston, Massachusetts
Problem  Pancreatic cancer
- Significant morbidity and mortality
- <7% overall survival rate
 >80% present with advanced disease
 Symptoms – physical and psychological
- High burden
- Predictably worsen - Palliative and hospice care provided at end of life
- Late referrals to palliative care (PC) – adverse effect on quality of life (QoL)
 Goal of treatment is largely palliative
Common Symptoms of Pancreatic Cancer
 Physical ‐ Pain, anorexia, weight loss, fatigue, jaundice, nausea/vomiting, fatigue, constipation, diarrhea
 Psychological ‐ Depression, anxiety, insomnia, and existential distress
 Complications associated with the disease ‐ thrombosis, biliary obstruction, gastric outlet obstruction
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Shining Light on Pancreatic Cancer
General Management Issues
 Reversal of common bile duct obstruction
 Symptom management
 Pain control
 Nutrition  Pancreatic enzyme replacement
 New onset diabetes
 Treatment of venous thrombosis
 Psychosocial support
What Palliative Care is and What it is Not
Palliative Care
It’s not about dying.
It’s about living.
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Shining Light on Pancreatic Cancer
Palliative Care Defined
Center for Medicaid and Medicare National Consensus Project • Patient, family‐centered care that optimizes QoL by anticipating, preventing, and treating suffering
• Addresses physical, intellectual, emotional, social, and spiritual needs
• Facilitates patient autonomy, access to information, and choice
• Aims to relieve suffering, to support best possible QoL for patients with advanced chronic or life‐threatening illnesses and their families
• Includes: ‒ General approach to patient care routinely integrated with disease‐
modifying therapies
‒ Growing practice specialty for highly trained specialist physicians, nurses, social workers, chaplains, etc. Components of Palliative Care
Multi‐
disciplinary Palliative Care Teams
Practical Support
Provided to patients and caregivers
Goals of Care (GOC)
Patient and Family
Traditional Models
Communication regarding achievable GOC and decision making that follows Dichotomous; either/or
Symptom Management
Physical, emotional and spiritual distress
Integrated Model
Provided simultaneously with curative or life prolonging treatment What Constitutes Palliative Care?
Can be delivered concurrently with life modifying therapy
Psychosocial support for patient and family
Minimization
of suffering Anticipation and planning for future symptoms to prevent suffering
Aggressive, well‐planned symptom control
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Maximization
of patient’s dignity and control
Protection from burdensome interventions
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Shining Light on Pancreatic Cancer
Models of Palliative Care Delivery
Dichotomous Model of Healthcare
Life‐
Prolonging Care
Palliative or Hospice Care
Disease Progression
Integrated Model of Healthcare
D
E
A
T
H
Disease Modifying Therapy
Death and Bereavement
Hospice
Palliative Care
Disease Progression
Eight Domains of Palliative Care: Developed by the National Consensus Project (NCP) and The National Quality Forum (NQF)
Domain 1
Domain 2
Domain 3
Structure and Process of Care
Physical Aspects of Care
Psychological and Psychiatric Aspects of Care
Domain 4
Social Aspects of Care
Framework Domain 5
Eight Domains of Quality Palliative Care
Spiritual, Religious and Existential Aspects of Care
Domain 6
Domain 7
Domain 8
Cultural Aspects of Care
Care of the Imminently Dying Patient
Ethical and Legal Aspects of Care
Integrating Palliative Care to Improve QoL
The ENABLE II Trial  Psycho‐educational palliative interventions
 Improved QoL and less depression
 Trend towards reduced symptom intensity
 Median survival improved (P=.14)
- Intervention group 14 months
- Control group 8.5 months © 2016 MediCom Worldwide, Inc.
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Shining Light on Pancreatic Cancer
Integrating Palliative Care to Improve QoL  Standard cancer care simultaneously with palliative care
 Improved QoL and reduced major depression
 Reduced ‘aggressiveness’  Less chemotherapy <14D before death
 More likely to receive hospice care; less likely to be hospitalized in last month of life
 Improved survival (P<.02)
- 11.6 months vs 8.9 months
Integrating Palliative Care to Improve QoL
 Palliative care + standard of care  Visits every month vs standard of care alone
 At 4 months, significant difference in the intervention group - QoL (FACIT) - Symptom severity (ESAS) - QoL at the end of life (QUAL‐E)
- Satisfaction with care (FAMCARE‐P16)
Consequences of Late Referrals to Palliative Care
 Compared to care at home with hospice:
- Care in ICU associated with 5x family risk of post‐traumatic stress disorder
- Care in hospital associated with 8.8x family risk of prolonged grief disorders © 2016 MediCom Worldwide, Inc.
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• Symptoms
• Quality of life
• Length of life
• Family satisfaction
• Family bereavement outcomes
• Care matched to patient Reduces Cost
Improves Quality
Palliative Care Improves Value • Hospital costs decrease
• Need for hospitalization/ ICU decreases
‐centered goals
Organizational Mandates
National and International Organizations Advocate for PC National Comprehensive Cancer Network (NCCN) IOM (2014) ‘Dying in America’
• Component of comprehensive cancer care throughout trajectory of illness
• Regardless of treatment goals
American Society of Clinical Oncologists (ASCO) (2012)
World Health Organization (WHO)
“…combined standard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and/or high symptom burden”
Palliative Care for People with Cancer
ONS Position Statement, November 2014
The Major Barrier: Access Oncologist
Palliative medicine
In 20 states
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1 for every 145 patients with a new cancer diagnosis
1 for every 1,300 people with serious illness
No access to post‐
graduate training in palliative education
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Palliative Care Delivery
 Primary or generalist‐level palliative care
 Specialist‐level palliative care Palliative Care Addresses Three Major Domains Patient‐family and professional communication Providing comfort
about achievable goals for care and the decision‐making that follows
physical, emotional, and spiritual
Effective and Patient‐centered Communication
Coordinated, communicated, continuity of care and support for practical needs of both patients and families in all settings during the patient’s illness
When to Discuss Palliative Care
 At the time of sharing diagnosis of chronic illness
- Relief of symptoms


Impact on person’s lifestyle
Impact on person’s self‐image
- Uncover the meaning that patient places on how to live with their illness
- Major changes in course of disease
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Shining Light on Pancreatic Cancer
Guiding Clinicians to Improve Communication
 Serious Illness Conversation Guide
- To help train and support clinicians when discussing goals of care
- This short simple guide assists the clinician in discussing:




Patients’ understanding of their illness
Patients’ preference for information
Patients’ preference for family involvement in care
Patients’ personal life goals, fears and anxieties, and trade‐offs they are willing to accept
Conclusions
 Patients with pancreatic cancer are faced with a chronic illness with many distressing symptoms
 Treatments are multimodal and aggressive, potentially having an overall negative impact on their QoL with limited survival
 Providing PC preferably early in the course of disease is ideal  Every clinician caring for patients needing PC should be adequately trained to provide the services
 Patients with refractory symptoms should be referred to the PC specialists
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Conclusions
 Implications with this model include:
- Restructuring all nursing and medical school curriculum to include key concepts of PC
- Funding is needed for PC education of health care providers  Patients and family members have a right to be educated about enormous benefits that PC can provide
Thank You
References available via downloadable slide set at: partnersinpancreaticcancer.com/ons2016 Panel Discussion/Q&A
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References
1.
2.
3.
4.
5.
6.
7.
8.
9.
Bakitas M, Lyons KD, Hegel MT, et al. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009;302(7):741‐749.
Bruera E, Hui D. Integrating supportive and palliative care in the trajectory of cancer: establishing goals and models of care. J Clin Oncol. 2010;28(25):4013‐4017.
Bruera E, Yennurajalingam S. Palliative care in advanced cancer patients: How and when? Oncologist. 2012;17(2):267‐273.
Bruera E, Michaud M, Vigano A, et al. Multidisciplinary symptom control clinic in a cancer center: A retrospective study. Support Care Cancer. 2001;9(3):162‐168.
Byock I. Completing the continuum of cancer care: integrating life‐prolongation and palliation. CA Cancer J Clin. 2000;50(2):123‐132.
Byock I. Palliative care and oncology: growing better together. J Clin Oncol. 2009;27(2):170‐171. Johnson CE, Girgis A, Paul CL, et al. Cancer specialists’ palliative care referral practices and perceptions: Results of a national survey. Palliat Med. 2008;22(1):51‐57. Casarett D, Pickard A, Bailey FA, et al. Do palliative care consultations improve patient outcomes? J Am Geriatr Soc. 2008;56(4):593‐599.
Fazal S, Saif MW. Supportive and palliative care of pancreatic cancer. JOP. 2007;8(2):240‐253.
References
10. Ferrell B, Paice J, Koczywas M. New standards and implications for improving quality of supportive oncology practice. J Clin Oncol. 2008;26(23):3824‐3831.
11. Ferrell B, Connor SR, Cordes A, et al. The National Agenda for Quality Palliative Care: The 12.
13.
14.
15.
16.
National Consensus Project and the National Quality Forum. J Pain Symptom Manage. 2007;33(6):737‐744.
Ferris FD, Bruera E, Cherny N, et al. Palliative cancer care a decade later: accomplishments, the need, next steps ‐‐ from the American Society of Clinical Oncology. J Clin Oncol. 2009;27(18):3052‐3058.
Follwell M, Burman D, Le LW, et al. Phase II study of an outpatient palliative care intervention in patients with metastatic cancer. J Clin Oncol. 2009;27(2):206‐213.
Gabriel M. Providing palliative care for the newly diagnosed cancer patient. Concepts and resources. Oncology (Williston Park). 2008;22(4 Suppl Nurse Ed):29‐33.
Gaertner J, Wolf J, Hallek M, et al. Standardizing integration of palliative care into comprehensive cancer therapy—a disease specific approach. Support Care Cancer. 2011;19(7):1037‐1043.
Gelfman LP, Meier DE, Morrison RS. Does palliative care improve quality? A survey of bereaved family members. J Pain Symptom Manage. 2008;36(1):22‐28.
References
17. Hidalgo M. Pancreatic cancer. N Engl J Med. 2010;362(17):1605‐1617.
18. Hui D, Elsayem A, De la Cruz M, et al. Availability and integration of palliative care at US cancer centers. JAMA. 2010;303(11):1054‐1061.
19. Labori KJ, Hjermstad MJ, Wester T, et al. Symptom profile and palliative care in advanced 20.
21.
22.
23.
24.
pancreatic cancer‐a prospective study. Support Care Cancer. 2006;14(11):1126‐1133.
Lagman R, Walsh D. Integration of palliative medicine into comprehensive cancer care. Semin Oncol. 2005;32(2):134‐138.
Lazenby JM, Saif MW. Palliative care from the beginning of treatment for advanced pancreatic cancer. Highlights from the “2010 ASCO Gastrointestinal Cancers Symposium”. Orlando, FL, USA. January 22‐24, 2010. JOP. 2010;11(2):154‐157.
Levy MH, Back A, Benedetti C, et al. NCCN clinical practice guidelines in oncology: palliative care. J Natl Compr Canc Netw. 2009;7(4):436‐473.
Lorenz KA, Lynn J, Dy SM, et al. Quality measures for symptoms of advanced cancer: A systematic review. J Clin Oncol. 2006;24:4933‐4938.
McNiff KK, Neuss MN, Jacobson JO, et al. Measuring supportive care in medical oncology practice: lessons learned from the quality oncology practice initiative. J Clin Oncol. 2008;26(23):3832‐3837.
© 2016 MediCom Worldwide, Inc.
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References
25. Meier DE, Casarett DJ, vonGunten CF, et al. Palliative medicine: politics and policy. J Palliat Med. 2010;13(2):141‐146.
26. Meier DE. Palliative care in U.S. hospitals: Implications for access to quality health care. 27.
28.
29.
30.
Testimony prepared for the United States Senate Special Committee on Aging. September 24, 2008.
Meier DE, Beresford L. Advanced care nurses in palliative care: a pivotal role and perspective. J Palliat Med. 2006;9(3):624‐627.
National Consensus Project for Quality Palliative Care (2009). Clinical practice guidelines for quality palliative care. (2nd Ed). United States of America. Accessed January 28, 2011 at www.nationalconsensusproject.org.
National Quality Forum: A national framework and preferred practices for palliative and hospice care quality. Washington D.C. Accessed April 20, 2016 at https://www.qualityforum.org/Publications/2006/12/A_National_Framework_and_Preferred
_Practices_for_Palliative_and_Hospice_Care_Quality.aspx.
Palliative care and hospice education training Act (2012). Accessed February 17, 2013 at www.govtrack.us/congress/bills/112/hr6155.
References
31. Passik SD, Breitbart WS. Depression in patients with pancreatic carcinoma. Diagnostic and treatment issues. Cancer. 1996;78(3 Suppl):615‐626.
32. Peppercorn JM, Smith TJ, Hleft PR, et al. American Society of Clinical Oncology Statement: Toward individualized care for patients with advanced cancer. J Clin Oncol. 2011;29:755‐760.
33. Polit DF, Hungler BP. Research designs for quantitative studies. In Nursing research: Principles 34.
35.
36.
37.
38.
and methods 6th ed. 1999;193‐218. Philadelphia: J. B. Lippincott Company. Quill TE, Abernethy AP. Generalist plus specialist palliative care‐creating a more sustainable model. N Engl J Med. 2013;368(13):1173‐1175.
Sanft TB, Von Roenn JH. Palliative care across the continuum of cancer care. J Natl Compr Canc Netw. 2009;7(4):481‐487.
Sauter PK, Coleman J. Pancreatic cancer: a continuum of care. Semin Oncol Nurs. 1999;15(1):36‐47.
Serious Illness Conversation Guide. Dana‐Farber Cancer Institute and Ariadne Labs. Accessed April 20, 2016 at https://www.ariadnelabs.org/resources/downloads/.
Sun V, Ferrell B, Juarez G, et al. Symptom concerns and quality of life in hepatobiliary cancers. Oncol Nurs Forum. 2008;35(3):E45‐52.
References
39. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non‐
small‐cell lung cancer. N Engl J Med. 2010;363(8):733‐742.
40. Temel JS, Jackson VA, Billings JA, et al. Phase II study: integrated palliative care in newly diagnosed advanced non‐small‐cell lung cancer patients. J Clin Oncol. 2007;25(17):2377‐2382.
41. Temel J, Greer J, Admane S, et al. Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non‐small cell lung cancer: Results of a randomized study of early palliative care. J Clin Oncol. 2011;29(17):2319‐2326.
42. Twaddle ML, Maxwell TL, Cassel JB, et al. Palliative care benchmarks from academic medical centers. J Palliat Med. 2007;10(1):86‐98. 43. Wright AA, Keating N, Balboni T, et al. Place of Death: Correlations with Quality of Life of patients with cancer and predictors of bereaved caregivers mental health. J Clin Oncol. 2010;28(29):4457‐4464.
44. Zafar SY, Currow DC, Daugherty C, et al. Standards for palliative care delivery in oncology settings. Cancer J. 2010;16(5):436‐443.
45. Zimmermann C, Riechelmann R, Krzyzanowska M, et al. Effectiveness of specialized palliative care: a systematic review. JAMA. 2008;299(14):1698‐1709.
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Panel Discussion Questions
1. The systemic treatment of PC can have multiple side effects that are particularly distressing for the patient. Diarrhea from irinotecan and peripheral neuropathy from oxaliplatin are a few. How can we as nurses manage these side effects and avoid them affecting a patient’s quality of life?
2. Communication with the patient, their family and the multidisciplinary team is crucial in the management of PC. What is a patient’s understanding of their disease? What do they want to know? How can we actively involve them and their family in the decisions of their treatment?
Panel Discussion
3.
4.
5.
PC is a rapidly developing and ultimately fatal cancer. It is difficult to detect and most often diagnosed at an advanced stage. How can health care providers increase public awareness regarding the possible prevention of pancreatic cancer? Are there screening tools for those with high risk factors?
PC has a high incidence of depression, anxiety, insomnia and existential distress. How can we help our patients not only manage the physical aspects of the treatment of pancreatic cancer but the psychosocial aspects as well?
Weight loss and cachexia are common in patients with PC and the etiology is multifactorial. What are measures we can incorporate into our plan of care to improve dietary/metabolic health, prevent further weight loss, and improve a patient’s QOL during treatment?
SHARE YOUR KNOWLEDGE
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